FDA.reportPublic FDA data

Dermaharmony Sulfur and Salicylic Acid

Product NDC
71819-006
11-digit product format
718190006
Labeler code
71819
Product ID
71819-006_29ba7e0c-ade1-9f28-e063-6294a90a0037
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid, Sulfur
Dosage form
LIQUID
Route
TOPICAL
Labeler
D3 Development, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-27
Substance
SALICYLIC ACID; SULFUR
Active strength
2; 5 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dermaharmony Sulfur and Salicylic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100mL
SULFUR5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ, 70FD1KFU70
Rxcui2286294

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-006-04Dermaharmony Sulfur and Salicylic Acid118 mL in 1 BOTTLE, PLASTICLIQUID1182
71819-006-10Dermaharmony Sulfur and Salicylic Acid296 mL in 1 BOTTLE, PLASTICLIQUID2962
71819-006-12Dermaharmony Sulfur and Salicylic Acid355 mL in 1 BOTTLE, PLASTICLIQUID3552
71819-006-64Dermaharmony Sulfur and Salicylic Acid1893 mL in 1 BOTTLE, PLASTICLIQUID18932
71819-006-99Dermaharmony Sulfur and Salicylic Acid3785 mL in 1 BOTTLE, PLASTICLIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-006DERMAHARMONY SULFUR AND SALICYLIC ACID (SALICYLIC ACID, SULFUR) LIQUID [D3 DEVELOPMENT, INC.]2Current NDC, Legacy NDC, 5 package rows20241222_a1c61da2-7e7a-430a-e053-2995a90ad594.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2286294salicylic acid 2 % / sulfur 5 % Medicated Liquid SoapPSNa1c61da2-7e7a-430a-e053-2995a90ad5942
2286294salicylic acid 20 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCDa1c61da2-7e7a-430a-e053-2995a90ad5942
2286294salicylic acid 2 % / sulfur 5 % Medicated Liquid SoapSYa1c61da2-7e7a-430a-e053-2995a90ad5942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71819-006-0471819000604118 mL in 1 BOTTLE, PLASTIC (71819-006-04) 118 ml2020-03-270000-00-00NoNoCurrent
71819-006-1071819000610296 mL in 1 BOTTLE, PLASTIC (71819-006-10) 296 ml2020-03-270000-00-00NoNoCurrent
71819-006-1271819000612355 mL in 1 BOTTLE, PLASTIC (71819-006-12) 355 ml2020-03-270000-00-00NoNoCurrent
71819-006-64718190006641893 mL in 1 BOTTLE, PLASTIC (71819-006-64) 1893 ml2020-03-270000-00-00NoNoCurrent
71819-006-99718190006993785 mL in 1 BOTTLE, PLASTIC (71819-006-99) 3785 ml2020-03-270000-00-00NoNoCurrent